William Reed Business Media Holiday video

Happy Holidays 2014 from William Reed Business Media!

18-Dec-2014 - The holidays are fast upon us, so let’s put ‘business’ to one side and get into the festive mood. To keep in the spirit of things, we’ve got a ‘gift’ for you – enjoy. Happy Holidays!

Crestor Manufacturing, photo c/o AstraZeneca

AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again

18-Dec-2014 - An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.

API supplier issues again cause FDA to reject Pozen drug candidates

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

FDA issues Form 483 to Hovione in Portugal

US FDA issues Form 483 to Hovione API facility in Portugal

18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

Putin Government's interest rate hike could not stop rouble slump earlier this week

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 - Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

CTC's new cell therapy plant will support UK SME biotech firms in commercial manufacture

Immunotherapy in the UK? National manufacturing site backed by GE

17-Dec-2014 - GE Healthcare has pledged its support and technology to a national £55m ($86m) Cell Therapy manufacturing centre in Stevenage, UK, set to launch in 2017.

Compounding the problem? US FDA sets up committee for compounding pharmacies

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

Nanoparticles as medical devices and for drug delivery

In nano-rod we trust: magnetic pulse tech breakthrough for cancer drug delivery

17-Dec-2014 - A magnetic pulse technology that can align and push nanoparticles to points distant to magnet surfaces could finally make magnets attractive for deep tissue drug delivery according to researchers.

The proposed rule would set up a new website where drug info can be updated electronically.

US FDA calls for prescribing info to be distributed electronically

17-Dec-2014 - The US FDA is now calling for prescribing information intended for health care professionals to be distributed electronically, with few exceptions.

Merck Serono hopes QR codes will put off counterfeiters. (Image: Karlis Dambrans)

Anti-counterfeiting: EMD Serono lets patients scan meds on iPhone

16-Dec-2014 - Patients and pharmacists can now use smartphones to check biologics are genuine with a new Merck Serono tech launched to combat counterfeiters' growing interest in high-value biopharma drugs.

Dangerous? The FDA is adding extra language to Geodon's black box warning

US FDA warns Pfizer antipsychotic linked to serious allergic reaction

16-Dec-2014 - The US FDA is requiring Pfizer to slap yet another warning label on its antipsychotic Geodon (ziprasidone).

Asian API makers could benefit from MES systems like PAS-X says Werum

Asian API exporters looking to process management IT systems, says Werum

16-Dec-2014 - Asian API makers are turning to ‘out-of-the-box’ Manufacturing Execution Systems (MES) to help manage documentation and control quality, according to IT solutions Werum.

No specks please, we're regulators; IPEC Americas finalises technically unavoidable particle profile (TUPP) guide

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

On the move: changes at EFPIA, Roche, Merck & Co.

On the move: changes at EFPIA, Roche, Merck & Co.

15-Dec-2014 - Novartis's CEO becomes President of EFPIA, a new head of R&D for Genentech, and more People on the Move.

Japan's Sosei Group buys peptide synthesis technology firm Jitsubo for $70m

Sosei looks to $23bn peptide market with acquisition of tech firm Jitsubo

15-Dec-2014 - Sosei Group Corporation is looking to peptides to replenish its pipeline through the $70m acquisition of technology firm Jitsubo.

AstraZeneca's Westborough, MA facility c/o WATERMAN DESIGN ASSOCIATES, INC.

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.

Indian CMO Kemwell has its Swedish headquarters in Uppsala Business Park, Sweden

After AZ R&D exit, CMOs anxious to keep pharma in the country

11-Dec-2014 - Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.

An inspector calls. (Image: George Redgrave/Flickr)

IPA says bad inspectors making Indian manufacturers fear visits

11-Dec-2014 - The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.

'American Idol' judges Steven Tyler, Jennifer Lopez and Randy Jackson did not conduct the Pfizer interviews. (Image: Fox)

Want to work for Pfizer? Get ready for ‘American Idol’ audition

10-Dec-2014 - Pfizer has revealed a unique way of hiring employees in Sweden it compares to “American Idol” auditions.

Sun and Ranbaxy merger will form India's largest pharma firm

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.